Lawsuit Filed Over Atrial Septal Defect from Zoloft Use by Mother

A 21 year-old Massachusetts woman has filed a Zoloft birth defect lawsuit against Pfizer, alleging that she suffered atrial septal defects as a result of her mother’s use of the popular antidepressant during pregnancy. 

The complaint (PDF) was filed by Tyreke Reese on June 19, in the U.S. District Court for the Eastern District of Missouri, alleging that Pfizer knew or should have known that side effects of Zoloft use during pregnancy could cause heart defects in children and accusing the drug maker of failing to adequately warn Reese’s mother or her doctor.

Reese was born in 1991 with a number of serious health problems, including an atrial septal defect. She has required surgery, extensive medical treatment and medical monitoring, the lawsuit claims.

Zoloft Atrial Septal Birth Defects

An atrial septal defect occurs when the wall between the two upper chambers of the heart fails to completely form. This allows blood to flow between the two chambers resulting in a build up of pressure in the lungs and shortness of breath. People born with an atrial septal defect face an increased risk of atrial fibrillation as adults, heart failure, stroke and hypertension.

In cases where the defect is significant, the child must undergo heart surgery in most cases. In some cases, however, a device to close the shunt between the two heart chambers can be implanted without surgery via a catheter.

Zoloft (sertraline) was introduced by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety. By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States.

Reese’s case joins a growing number of lawsuits over Zoloft birth defects filed on behalf of children who have experienced problems such as heart defects, persistent pulmonary hypertension in newborns, spina bifida and other defects or malformations.

According to allegations raised in Reese’s complaint and other similar lawsuits, Pfizer knew from clinical trials that Zoloft may cause problems for children born to women who used the medication while pregnant, but failed to adequately warn consumers or the medical community about the potential risks for women of child-bearing age.

Reese accuses the company of designing a defective drug, failure to warn, negligence and fraud. She is seeking compensatory damages and punitive damages as well.

The lawsuit is likely to be transferred into the Zoloft MDL, or multidistrict litigation, which formed in April by the U.S. Judicial Panel on Multidistrict Litigation, centralizing cases filed in federal district courts throughout the country before U.S. District Judge Cynthia Rufe in the U.S. District Court for the Eastern District of Pennsylvania.